Lima, Peru, Jun 18, 2004 / 12:00 am (CNA).- A spokeswoman for the Food and Drug Administration (FDA) has told CNA that the government agency has not ruled out the anti-implantation effect of Levonorgestrel—the generic name for the morning after pill—because it has not received “safety information” to make such a determination.
This week Peruvian Minister of Health, Pilar Mazzetti, told reporters the FDA data on the abortion pill is from 2002 and that “recent studies” confirm that the drug’s third mechanism—which is the focal point of the controversy—has been ruled out.

An FDA statement from May 7, 2004, said the morning after pill functions primarily by preventing ovulation, but it can also prevent fertilization, and if fertilization has already taken place, it can prevent the fertilized ovum from implanting itself in the uterus.

This third mechanism is what has caused the controversy in Peru because the Peruvian constitution grants protection to human life from the moment of conception, not implantation. By denying the anti-implantation effect, Mazzetti is attempting to get around charges that her decision to distribute the drug as part of family planning policy is unconstitutional.

According to Susan Cruzan, public relations specialist of the FDA, the agency’s statement of May 7, 2004, only reiterates that the first mechanism—prevention of ovulation—is the only one that has been confirmed. The possibility that the drug prevents fertilization and implantation has not been ruled out.

Asked about the recent studies cited by Mazzetti, Cruzan said, “It’s really up to the manufacturer to submit that information to the Food and Drug Administration” because “the manufacturers are the ones that should make the labeling changes.”

“What you can do is call the company and make sure that they have that data and essentially the companies are required to send any new info that is related to the Food and Drug Administration, specifically if it relates to safety information. So again it’s really up to the manufacturer to submit that information to the food and drug administration and certainly people can call that to our attention,” said Cruzan.

She added that “the way that FDA operates, the FDA will have to see those studies and review them to make a determination based on that. We make our decisions based on science and the data that is submitted to the agency.”

In addition, Cruzan said that “what would have to happen in order for FDA to change the information that is put out there is that the company would have to submit that data and FDA would then have to update the label.”

“Its a scientific review process,” Cruzan said. “You can’t just say that, ‘Oh well you heard through us’. Usually what happens is that it will have to go through the actual manufacturers of those products. You know the manufacturers are the ones that should make the labeling changes.”